Olema Oncology · 2 weeks ago
Senior Manager, Global Regulatory Affairs Strategy
San Francisco, CA
Full-time
Hybrid
Senior Level
$176K/yr - $188K/yr
5+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Manager, Global Regulatory Affairs Strategy, you will provide regulatory strategy support in partnership with cross-functional teams and manage regulatory aspects through all phases of development.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Michelle Knobel
Responsibilities
Support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
Contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
Assist in risk assessment and mitigation planning for regulatory deliverables
Qualification
Required
Bachelor's degree in a scientific discipline required
Minimum 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry
Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence
Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
Experience collaborating in cross-functional, matrixed teams
Experience working with CROs and other partners
Strong organizational, project management, and problem-solving skills
Excellent oral, written, and presentation skills
Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
Self-starter with the ability to work both independently and within teams
Preferred
Advanced degree (MS, PharmD, PhD)
Oncology therapeutic area experience
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase